First Vioxx Ruling

The VIGOR study was discussed at a February 2001 meeting of the FDA's Arthritis Advisory Committee, and the new safety information from this study was added to the labeling for Vioxx in April 2002. But the FDA did not ask Merck to pull the drug from the market. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx. (The FDA has published a comprehensive timeline of Merck's and its own activities with relation to Vioxx at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090B1_04_E-FDA-TAB-C.htm.)

Merck's eventual decision to withdraw Vioxx from the market in 2004 was based on data obtained from a trial comparing the drug to a placebo to see if Vioxx 25 mg was effective in preventing the recurrence of colon polyps. This trial was halted before it could be finished because patients taking part in the tests showed an increased risk for serious cardiovascular events, such as heart attacks and strokes, after 18 months of continuous treatment with Vioxx compared with placebo. Acting FDA Commissioner Dr. Lester M. Crawford said in a statement issued at the time the drug was pulled from the market that “[a]lthough the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo.” Crawford added that the FDA would be closely monitoring other drugs in this class for similar side effects. “All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician.”

A Dimming Future for Vioxx

This turn of events came as a major disappointment to those interested in Merck's fortunes, as the drug maker had predicted a glowing future for Vioxx when it first came on the market. In its annual report for the year 2000, Merck noted that in less than 2 years' time Vioxx had become the fastest-growing branded prescription drug for osteoarthritis and acute pain, and was Merck's second largest-selling medicine. Global sales that year exceeded $2 billion, with Vioxx accounting for approximately 20% of the world's market for arthritis and pain medications. Merck's 2000 report noted a potential for use of Vioxx to treat rheumatoid arthritis, colon polyps and Alzheimer's disease. This in spite of the fact that the report also contained information about the VIGOR study and its showing of increased risk of heart complications with the use of Vioxx.

Contrast Merck's sunny predictions of 2000 with the scene today. Plaintiff firms are still recruiting plaintiffs by the thousands. For example, the Lanier Law Firm, which is handling the Ernst case, states on its Web site that anyone injured by Vioxx should get in touch with the firm because their experience gives them a “significant head start over other firms only now scrambling to organize cases against Vioxx manufacturer Merck Pharmaceuticals and the various medical institutions where it was prescribed.” And there are many such “other firms.” Currently, nearly 4000 state and federal lawsuits are pending, with solicitations like the Lanier Law Firm's and publicity over consumer adverse events likely to cause that number to grow. The first federal Vioxx personal injury case is set to go to trial on Nov. 28 in the U.S. District Court for the Eastern District of Louisiana.

Government entities are adding to Merck's woes. Texas has already filed a suit against the company, claiming it paid for millions of dollars' worth of prescriptions through its Medicaid program for a product that Merck knew was dangerous. Merck is attempting to have that state court action removed to federal court, a move that would thwart Texas' attempt to recover treble damages under the state's fraud statute.

Add to these legal troubles the potential for stockholder suits and criminal charges, and it's easy to see that Merck has quite a problem for itself.

The Ernst Case

Robert Ernst was a 59-year-old Wal-Mart employee at the time of his death in May 2001. He died in his bed of what an autopsy report says was a heart arrhythmia.

In his opening statement on behalf of plaintiffs Carol Ernst and her deceased husband's children, Hous-ton attorney W. Mark Lanier accused Merck of putting marketing and the pursuit of profits above concerns for consumer safety. During his passionate remarks to the jury, Lanier displayed the phrase “Merck-y ethics” on a screen and promised to prove that Merck knew of the dangers posed by the use of Vioxx long before the drug was pulled from the market in September 2004, but failed to do anything about it because the pain medication was so profitable.

Merck claimed that Vioxx had never been shown to cause heart arrhythmia, so could not have been the cause of Ernst's death. However, against defense objections, Lanier was permitted to present a videotaped deposition of Dr. Maria M. Araneta, the coroner who performed the autopsy on Ernst, and her testimony was quite damaging to Merck's defense. Although Dr. Araneta wrote in her autopsy report that Ernst died of a heart arrhythmia caused by hardening of the arteries, she opined in deposition testimony that a blood clot interfered with the flow of blood to Ernst's heart, thus causing the arrhythmia. Other plaintiff experts whose testimony was presented at trial agreed with this theory. Merck's attorneys, who were apparently relying heavily on the statements made in the autopsy report, presented the testimony of their expert, Dr. Thomas M. Wheeler, head pathologist at Baylor University, to show that clogged arteries were the cause of Ernst's arrhythmia, not his Vioxx use.

Merck attorney David C. Kiernan of Washington, DC's Williams & Connolly, pointed out in his opening statements to the five women and seven men on the jury that Vioxx had been tested for 8 years prior to its approval by the FDA and that 10,000 patients – not merely the 1500 required for FDA-compliant trials – took part in the studies. Of those 10,000 patients, 5400 were given Vioxx for up to 18 months.

The Damages

While the legal team for Merck presented its case on a scientific level, Lanier went the emotional route. Ernst and wife Carol had been married less than a year when he died, but had dated for a few years before marrying. In testimony aimed at showing Robert Ernst was far more valuable as a human being than his meager remaining earning potential as a 59-year-old Wal-Mart employee would imply, Carol Ernst's daughter, Shawna Sherrill, took the stand on her mother's behalf and told the jury how distraught her mother was over the death of her husband. She said that her mother's life up until she met Robert Ernst was a hard one, colored by divorce and the difficulties of being a single mother to four children.

Carol Ernst echoed that testimony when she was called to the stand as the last plaintiff witness. She was cross-examined for nearly an hour and a half by defense attorney Gerry Lowry, who elicited an admission that Robert Ernst had not worked steadily in the last 2 years of his life. Lowry was also able to get into evidence the fact that Carol Ernst contacted an attorney about a possible lawsuit months before she sought grief counseling. In legal circles, there was some debate as to whether it had been wise to cross-examine a grieving widow, especially at such length.

In the end, Lanier's strategy won the day. The stunning amount the jury awarded as punitive damages will be automatically reduced to less than $2 million under Texas' tort-reform measures. Still, the $24.5 million award for economic losses and mental anguish is huge and was clearly meant to send a message to Merck and to other drug manufacturers.

Jonathan Skidmore of Fulbright & Jaworski, a member of Merck's defense team, said in a statement issued by Merck, “This case did not call for punitive damages. Merck acted responsibly – from researching Vioxx prior to approval in clinical trials involving almost 10,000 patients – to monitoring the medicine while it was on the market – to voluntarily withdrawing the medicine when it did.” The company plans to appeal, it says, based on errors it claims were made when the court let in evidence that was irrelevant and prejudicial to the defendant, allowed unqualified experts to testify and permitted surprise witnesses to give testimony.

Merck & Co., founded in 1891, has a slogan — what it calls its “guiding philosophy.” That philosophy is, “patients first.” In the first of many Vioxx trials expected to be litigated in state and federal courts across the country, the jury wasn't buying it. On Aug. 19, after a month-long trial, ten out of 12 jurors — the number needed to return a verdict of guilty — found Merck liable to the plaintiffs, survivors of a man who took Vioxx for pain relief. The damages award was staggering: $24.5 million in economic losses and compensation for mental anguish and $229 million in punitive damages.

One of Company's Leading Products May Be Its Undoing

Vioxx, the trade name of the generic drug rofecoxib, gained FDA approval in May 1999 for the treatment of osteoarthritis, menstrual pain and the management of acute pain in adults. The original safety database included approximately 5000 patients on Vioxx and did not, according to the FDA, show an increased risk of heart attack or stroke. www.fda.gov/cder/drug/infopage/vioxx/vioxxQA.htm. Merck later conducted a study it called VIGOR (VIOXX GI Outcomes Research), which was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding. The results of that study, submitted to the FDA in June 2000, did indeed show that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID. It also turned up another, less fortuitous piece of news for Merck: Participants on Vioxx experienced a greater number of heart attacks than those not taking that medication.

The VIGOR study was discussed at a February 2001 meeting of the FDA's Arthritis Advisory Committee, and the new safety information from this study was added to the labeling for Vioxx in April 2002. But the FDA did not ask Merck to pull the drug from the market. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx. (The FDA has published a comprehensive timeline of Merck's and its own activities with relation to Vioxx at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090B1_04_E-FDA-TAB-C.htm.)

Merck's eventual decision to withdraw Vioxx from the market in 2004 was based on data obtained from a trial comparing the drug to a placebo to see if Vioxx 25 mg was effective in preventing the recurrence of colon polyps. This trial was halted before it could be finished because patients taking part in the tests showed an increased risk for serious cardiovascular events, such as heart attacks and strokes, after 18 months of continuous treatment with Vioxx compared with placebo. Acting FDA Commissioner Dr. Lester M. Crawford said in a statement issued at the time the drug was pulled from the market that “[a]lthough the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo.” Crawford added that the FDA would be closely monitoring other drugs in this class for similar side effects. “All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician.”

A Dimming Future for Vioxx

This turn of events came as a major disappointment to those interested in Merck's fortunes, as the drug maker had predicted a glowing future for Vioxx when it first came on the market. In its annual report for the year 2000, Merck noted that in less than 2 years' time Vioxx had become the fastest-growing branded prescription drug for osteoarthritis and acute pain, and was Merck's second largest-selling medicine. Global sales that year exceeded $2 billion, with Vioxx accounting for approximately 20% of the world's market for arthritis and pain medications. Merck's 2000 report noted a potential for use of Vioxx to treat rheumatoid arthritis, colon polyps and Alzheimer's disease. This in spite of the fact that the report also contained information about the VIGOR study and its showing of increased risk of heart complications with the use of Vioxx.

Contrast Merck's sunny predictions of 2000 with the scene today. Plaintiff firms are still recruiting plaintiffs by the thousands. For example, the Lanier Law Firm, which is handling the Ernst case, states on its Web site that anyone injured by Vioxx should get in touch with the firm because their experience gives them a “significant head start over other firms only now scrambling to organize cases against Vioxx manufacturer Merck Pharmaceuticals and the various medical institutions where it was prescribed.” And there are many such “other firms.” Currently, nearly 4000 state and federal lawsuits are pending, with solicitations like the Lanier Law Firm's and publicity over consumer adverse events likely to cause that number to grow. The first federal Vioxx personal injury case is set to go to trial on Nov. 28 in the U.S. District Court for the Eastern District of Louisiana.

Government entities are adding to Merck's woes. Texas has already filed a suit against the company, claiming it paid for millions of dollars' worth of prescriptions through its Medicaid program for a product that Merck knew was dangerous. Merck is attempting to have that state court action removed to federal court, a move that would thwart Texas' attempt to recover treble damages under the state's fraud statute.

Add to these legal troubles the potential for stockholder suits and criminal charges, and it's easy to see that Merck has quite a problem for itself.

The Ernst Case

Robert Ernst was a 59-year-old Wal-Mart employee at the time of his death in May 2001. He died in his bed of what an autopsy report says was a heart arrhythmia.

In his opening statement on behalf of plaintiffs Carol Ernst and her deceased husband's children, Hous-ton attorney W. Mark Lanier accused Merck of putting marketing and the pursuit of profits above concerns for consumer safety. During his passionate remarks to the jury, Lanier displayed the phrase “Merck-y ethics” on a screen and promised to prove that Merck knew of the dangers posed by the use of Vioxx long before the drug was pulled from the market in September 2004, but failed to do anything about it because the pain medication was so profitable.

Merck claimed that Vioxx had never been shown to cause heart arrhythmia, so could not have been the cause of Ernst's death. However, against defense objections, Lanier was permitted to present a videotaped deposition of Dr. Maria M. Araneta, the coroner who performed the autopsy on Ernst, and her testimony was quite damaging to Merck's defense. Although Dr. Araneta wrote in her autopsy report that Ernst died of a heart arrhythmia caused by hardening of the arteries, she opined in deposition testimony that a blood clot interfered with the flow of blood to Ernst's heart, thus causing the arrhythmia. Other plaintiff experts whose testimony was presented at trial agreed with this theory. Merck's attorneys, who were apparently relying heavily on the statements made in the autopsy report, presented the testimony of their expert, Dr. Thomas M. Wheeler, head pathologist at Baylor University, to show that clogged arteries were the cause of Ernst's arrhythmia, not his Vioxx use.

Merck attorney David C. Kiernan of Washington, DC's Williams & Connolly, pointed out in his opening statements to the five women and seven men on the jury that Vioxx had been tested for 8 years prior to its approval by the FDA and that 10,000 patients – not merely the 1500 required for FDA-compliant trials – took part in the studies. Of those 10,000 patients, 5400 were given Vioxx for up to 18 months.

The Damages

While the legal team for Merck presented its case on a scientific level, Lanier went the emotional route. Ernst and wife Carol had been married less than a year when he died, but had dated for a few years before marrying. In testimony aimed at showing Robert Ernst was far more valuable as a human being than his meager remaining earning potential as a 59-year-old Wal-Mart employee would imply, Carol Ernst's daughter, Shawna Sherrill, took the stand on her mother's behalf and told the jury how distraught her mother was over the death of her husband. She said that her mother's life up until she met Robert Ernst was a hard one, colored by divorce and the difficulties of being a single mother to four children.

Carol Ernst echoed that testimony when she was called to the stand as the last plaintiff witness. She was cross-examined for nearly an hour and a half by defense attorney Gerry Lowry, who elicited an admission that Robert Ernst had not worked steadily in the last 2 years of his life. Lowry was also able to get into evidence the fact that Carol Ernst contacted an attorney about a possible lawsuit months before she sought grief counseling. In legal circles, there was some debate as to whether it had been wise to cross-examine a grieving widow, especially at such length.

In the end, Lanier's strategy won the day. The stunning amount the jury awarded as punitive damages will be automatically reduced to less than $2 million under Texas' tort-reform measures. Still, the $24.5 million award for economic losses and mental anguish is huge and was clearly meant to send a message to Merck and to other drug manufacturers.

Jonathan Skidmore of Fulbright & Jaworski, a member of Merck's defense team, said in a statement issued by Merck, “This case did not call for punitive damages. Merck acted responsibly – from researching Vioxx prior to approval in clinical trials involving almost 10,000 patients – to monitoring the medicine while it was on the market – to voluntarily withdrawing the medicine when it did.” The company plans to appeal, it says, based on errors it claims were made when the court let in evidence that was irrelevant and prejudicial to the defendant, allowed unqualified experts to testify and permitted surprise witnesses to give testimony.